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COMPLIANCE AND IMPORT/

EXPORT DURING

COVID-19

SUSAN DANKS

HEAD OF CUSTOMS

AND REGULATORY

COMPLIANCE

FREIGHT & TRADE

ALLIANCE (FTA)

THE THERAPEUTIC GOODS

ADMINISTRATION (TGA)

• Part of Federal Department of Health

• Regulates medicines, biologicals and devices, including medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.

• TGA does not regulate veterinary medicines and appliances, cosmetics or chemicals

• Australian Register of Therapeutic Goods (ARTG)

• Sponsors

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TGA REGULATION

What is a Therapeutic Good

Listing on the Australian Register of Therapeutic Goods (ARTG)

Registration as a sponsor

Goods not complying with the above are a Prohibited Import

ARTG

Medical devices must be entered on the

ARTG before they can be lawfully:

• manufactured for supply within

Australia or elsewhere;

• supplied in Australia;

• imported into Australia;

• exported from Australia;

• arranged to import, export or

manufacture the therapeutic goods.

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SPONSORS

A sponsor is the name for the person or company who is legally responsible for supplying a device in Australia is called the “sponsor”.

“Supply” includes sale, exchange, gift, lease, loan, hire or hire purchase.

Devices and medication can only be imported and supplied by the approved Sponsor (i.e. importer), or a person acting on their behalf

PENALTIES FOR NON COMPLIANCE

Civil or criminal

penalties

Up to 5 years imprisonment;

and/or

5000 penalty units

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EXPEDITED COVID-19

MEDICAL DEVICE TGA

APPROVAL PROCESS

• TGA is offering an expedited assessment

process for all medical devices associated

with the detection, prevention and

treatment of COVID-19.

• To ensure applications are rapidly assessed

once an application has been submitted,

sponsors should email devices@tga.gov.au

and provide supporting technical files and

data for assessment.

LABELLING OF MEDICAL DEVICES

• Refer Principle 13 of Sch 1 of the Therapeutic Goods (Medical Devices) Regulations 2002

• All labels must include the manufacturer's name and address;

• All labels must include instructions for use and other prescribed information. Refer the Regulations but it may include batch numbers, use by date/date of manufacture, handling, storage, warnings, restrictions as to use, special operating instructions. As well as if its for single use, and/or sterile

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TEST KITS INCLUDED

ON THE ARTG FOR SUPPLY IN AUSTRALIA

• The supply of self test-kits is prohibited

under the Therapeutic Goods (Excluded

Purposes) Specification 2010

• Emergency exemption for some diagnostic

kits to all (inc public and private) Australian

accredited pathology laboratories under

the Therapeutic Goods (Medical Devices—

Accredited Pathology Laboratories) (COVID-

19 Emergency) Exemption 2020

HAND SANITISERS

• These are either:

• A cosmetic regulated by ACCC / NICNAS; or

• A therapeutic good regulated by TGA

• The control depends upon how they are used/ advertised.

• NB: Some TGA products are excluded for the duration of the pandemic

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HAND SANITISERS ARE NOTREGULATED BY TGA IF THEY:

• are for personal or domestic use only and not

for use in a health care setting (inc aged care

homes), and

• have claims that are limited to general low-level

activity against bacteria or germs (for example,

kills 99.9% of germs), and

• have no claims against viruses, and

• contain only low-risk ingredients (i.e. does not

contain a substance included in Schedules 2, 3, 4

or 8 of the Poisons Standard).

HAND SANITISERS REGULATED BY NICNAS / ACCC

The controls on these goods are exercised by NICNAS / ACCC: • NICNAS regulates the

ingredients used in goods regarded as cosmetics.

• The ACCC regulates the labelling of goods regarded as cosmetics.

Hand sanitisers that are cosmetics

can only make general claims such as that the product "kills

99.9% of germs".

The Therapeutic Goods (Excluded

Goods) Determination

2018 sets out the circumstances

when antibacterial skin preparations

are not therapeutic goods.

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HAND SANITISERS REGULATED BY THE TGA

• These

• claim to kill specific organisms (e.g. E.coli or

viruses), and/or

• are to be used in clinics or hospitals.

• They must be on the Australian Register of

Therapeutic Goods (ARTG); and

• The importer / manufacturer must be

registered with TGA as a sponsor even if

identical goods are produced /

manufactured by other parties.

CERTAIN SPECIFIC HAND SANITISERS ARE EXCLUDED FROM TGA FOR THE DURATION OF THE PANDEMIC

The final formulation of the hand sanitiser must contain only the following ingredients:

EITHER ethanol 80% v/v (pharmacopoeial grade or food standard grade) ORisopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;

sterile distilled water or boiled cold water;

glycerol 1.45% v/v (pharmacopoeial grade);

hydrogen peroxide 0.125% v/v (pharmacopoeial grade); and

does not contain any other active or inactive ingredients, including colours, fragrances or emollients.

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HAND SANITISERS ARE A DANGEROUS GOOD

DANGEROUS GOODS - AIRCRAFT

• Specimens of Covid-19 being shipped to laboratories for analysis or

confirmation of diagnosis as cargo and potentially in mail;

• Alcohol-based hand sanitizers as air cargo

• Alcohol-based hand sanitizers uplifted in the cabin for use by crew members

as operator equipment; and

• Alcohol-based hand sanitizers carried by passengers and crew members in

checked and carry-on baggage.

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SUSPECTED COMMUNICABLE DISEASE: GUIDELINES FOR CARGO AND BAGGAGE HANDLERS

• Hand sanitiser containing alcohol is a Dangerous Good for carriage;

• During the Severe Acute Respiratory Syndrome (SARS) outbreak, the WHO declared there was no evidence that the infection had been or could be transmitted by cargo or baggage handling, but• Don’t handle packages visibly dirty from

blood or body fluids.

• Wash your hands often to prevent other infectious diseases. .

SAFETY DATA SHEETS ARE REQUIRED FOR ALL HAND SANITISERS, REGARDLESS OF THE CLASS, WITH DATA INCLUDING

.

• In response to the COVID-19 pandemic, UL is making SDS for TGA excluded hand sanitisers freely available to manufacturers and importers. Refer their website.

• Safe Work Australia has further information

the chemical’s identity and ingredients safe handling and storage procedures

health and physical hazards disposal considerations

first aid and firefighting methods

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IMPORTING COVID-19

PRODUCTS INTO

AUSTRALIA

• Regulatory framework managed by TGA applies to any goods intended for use in a therapeutic environment

• New importers should be referred to TGA website if not familiar with the requirements https://www.tga.gov.au/industry and the video at https://tga.gov.au/summary-supplying-therapeutic-goods-australia

• TGA take a risk based approach to importing PPE and medical devices

• Penalties can apply for importing unregistered goods

• Some exemptions apply

UNDENATURED ETHYL ALCOHOL IMPORTED TO MANUFACTURE HAND SANITISER

Enter to bond licensed by both ATO and ABF on a N20

If the warehouse is licensed to produce or distil spirits no further action is required by you. If not so licensed, they should apply – applications are being fast tracked.

The bond warehouse will lodge a N30 at the end of its settlement period to acquit the deliveries made into the Australian domestic market and/or the excise equivalent imported goods used in excise manufacture during that period.

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PERSONAL PROTECTIVE EQUIPMENT (PPE)E.G. FACE MASKS, GLOVES, FACE

SHIELDS, GOGGLES AND

GOWNS

PPE / MEDICAL GOODS IMPORTED WHERE EVIDENCE OF TGA APPROVAL IS NOT HELD

• Risk based approach;

• ABF will refer goods to TGA for assessment

• TGA will determine if goods are in breach of the Therapeutic Goods Act

• If they are in breach TGA will issue a direction to ABF and the goods will be

seized

• Goods not in breach will be released

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NOT ALL FACE MASKS AND GOWNS ARE REGULATED BY THE TGA

Under the Therapeutic Goods

(Declared Goods) Order

2019, non sterile protective

or safety apparel or

equipment such as dust masks

is not controlled when of a

type promoted and used:

• in the home; or

• for occupational or

recreational use.

e.g. dust masks for industry

PPE REGULATED BY TGA

Face masks or gowns, presented, labelled or claimed as therapeutic use, e.g. labelled for surgical use, or to reduce or prevent the transmission of disease or bacteria or viruses, meet the definition of a medical device and are regulated by the TGA under the Act.

ARTG listing required

Sponsor required

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THERAPEUTIC GOODS (MEDICAL DEVICES – FACE MASKS AND OTHER ARTICLES) (COVID-19 EMERGENCY) EXEMPTION 2020

This exemption, is only for supplies of some kinds of medical devices to the Aust Govt Dept of Health for the National Stockpile.

It only applies to goods not in the ARTG for that supplier

It does not permit the general supply of these items to hospitals etc

TWO NEW EXPORT

REQUIREMENTS FOR PPE &

DEVICES EXPORTED

FROM CHINA ARE CAUSING

DELAYS

• Joint Announcement No 5 of 1 April on export of

COVID-19 test kits, medical or surgical masks,

medical protective clothing, ventilators and infrared

thermometers

• National Medical Product Registration (NMPA)

Certificate from the supplier required for

export;

• Does the supplier for COVID-19 test kits have

NMPA certification for export

• NMPA = CIQ certificate

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TWO NEW EXPORT

REQUIREMENTS FOR PPE &

DEVICES EXPORTED

FROM CHINA ARE CAUSING

DELAYS

• China Customs Announcement No 53 of 10 April 2020 on quality inspection of PPE and medical products

• Export verification of goods against documentation

• Packaging checked – exports declared as non-medical cannot have any medical standards, accreditation or suggestive language on the packaging (eg N95 masks for industrial use)

• Significant export freight delays as a consequence both of reduced capacity and the two new export exams.

CLEANERS AND DISINFECTANTS

What disinfectants claim to do will determine

how they are regulated by the TGA. Claims

may be made on the labels, instructions for

use or on promotional material.

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ITEM 57 – GOODS TO BE USED IN RESPONSE TO THE COVID-19 PANDEMIC

Goods, as prescribed by by-law, if:(a) the goods are medical products or hygiene products; and

(b) the goods are capable of use in combating the novel coronavirus that causes the disease known as COVID-19; and

(c) the time for working out the rate of duty on the goods is in the period beginning on 1 February 2020 and ending at the end of 31 July 2020

• Treatment Code 757 applies

BYLAW 2019608 TO ITEM 57 – GOODS TO BE USED IN RESPONSE TO THE COVID-19 PANDEMICEFFECTIVE 1 FEB 2020

(a) any of the following equipment that, when worn, is capable of limiting the transmission of organisms to humans:

(i) face masks;

(ii) gloves;

(iii) clothes or gowns;

(iv) goggles, glasses, eye visors or face shields;

(b) disinfectant preparations classified to heading 3808 in Schedule 3 to the Customs Tariff, excluding hand sanitisers;

(c) soaps;(d) COVID-19 test kits, reagents and viral transport media.

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NEW TEMPORARY EXPORT CONTROLS FOR COVID-19 RELATED GOODS

ACN 202 / 15 refers

New export controls on non-commercialexport of certain PPE, such as gloves, gowns, goggles, alcohol wipe and sanitiser

The controls will remain in force while the Biosecurity Declaration 2020 is in force

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